Saint Mary s Hospital Gynaecology Service Warrell Unit What do I need to know about tapes for Stress Incontinence? Information for Patients
What is a tape? A tape is a strip of artificial mesh material used to treat stress incontinence. It supports the tap mechanism of the bladder to stop it from leaking during activities such as coughing, sneezing and exercise. There are many different types of tape available. They are all put in through a small cut on the front wall of the vagina. Some lie behind the pubic bone (retropubic tapes) and some lie across the pelvis from groin to groin (transobturator tapes). They use a permanent type of mesh that stays in the body forever. What is the advantage of using a tape? During operations for stress incontinence, the surgeon tries to support the tap mechanism of the bladder to stop it moving about during activities such as coughing, sneezing and exercise. This can be done using permanent stitches (colposuspension) or a strip of the strong tendon in the tummy wall (fascial sling). Both of these operations are available in the Warrell Unit and information leaflets are available which give more detail about the procedures. Both a colposuspension and a fascial sling are major operations. They involve a stay in hospital, having a catheter in for a few days and require some time to recover once you go home. They also have risks of complications. Tape operations for stress incontinence were developed to avoid some of the complications of these bigger operations. They can also be done as a day-case operation for most women, meaning you won t need to stay in hospital overnight and have a faster recovery back to your usual activities. The permanent tape also provides lifelong strength and therefore, lasts longer than the other operations. 2
What are the disadvantages of a permanent tape? Unfortunately, there are disadvantages of inserting any artificial material into the body. Rarely, the material can become infected or recognized by the body as foreign and be rejected. Scar tissue can form around the tape causing pain. Over time, the tape can wear through the tissues so that it pokes through the vaginal skin, or less commonly, through the wall of the urethra or bladder. This is called erosion and can occur many years after the tape has been put in. All tapes are not the same and some seem to have much lower risks of problems than others. However, erosion often needs further surgery to remove parts or all of the tape. Removing tape from the urethra or bladder can be complicated surgery needing a catheter afterwards for several days or weeks. In contrast, stress incontinence is not dangerous or harmful condition. The risk of having complications from the tape needs to be weighed carefully against the bother you are getting from your condition. If I would like a tape, what can be done to reduce the risk of a tape complication? If, after discussing the options for your stress incontinence, you would like a tape procedure, we can offer you one. The tape used in The Warrell Unit is called a Tension Free Vaginal Tape (TVT) and there is a leaflet available to give you more information. The TVT is a retropubic tape made of permanent material. The risk of infection can be reduced by giving you a dose of antibiotics at the start of the operation. A camera study of the urethra and bladder will be performed during the operation to ensure the tape is in the correct position. 3
The TVT has a low risk of other complications. The risk of having pain once the wounds have healed is less than 1 in 100. The risk of having problems with the TVT wearing through tissues (erosion) is around 1 in every 100 women who have a TVT. Smokers are more likely to have tape erosion, so stopping smoking is likely to help reduce the risk. What do other doctors/organisations think about using tapes? Surgeons have had concerns for many years about the potential for tapes to cause complications in some women. Several studies have been performed to try to find out exactly what the advantages and disadvantages of the various tapes are. So far, the results have suggested that we should continue to offer the TVT as it works well and has a low risk of complications. The FDA (who regulate tapes in the USA) have also been concerned about tape complications. They have published advice for both doctors and patients in the USA about using tapes. They are most concerned about some of the newer tapes for stress incontinence. NICE have also published advice for doctors about using tapes in the UK. How will I know if I have developed a problem with my tape? Although problems can occur, most women will never have a problem with their tape. Often, the symptoms of tape problems are non-specific. This means that they could be caused by other things and not your tape. However, problems with tape can be difficult to spot and being seen at a specialist centre, such as the Warrell Unit, can be very helpful. 4
Tape problems can give symptoms such as: Pain in the vagina or bladder. Pain during sex for you or your partner. Discharge or bleeding from the vagina. Frequent urinary tract infections. Worsening problems with having to rush to pass water or going to pass water very frequently. If you have concerns, you should discuss them with your doctor at the Warrell Unit. If you do experience a complication, you can expect us to: Explain the diagnosis and treatment necessary to you in a way that you can understand Report the ape complication to the relevant authority (in the UK this is the MHRA) in a way that protects your medical confidentiality. I have had a tape inserted in the past, should I be worried? As it says above, most women will never have a problem with their tape. If you have no symptoms which might suggest a problem, there is no need to worry. If symptoms start and you are worried, speak to your GP and ask to see a specialist if necessary. Stopping smoking might help to reduce the risk of a problem occurring in the future. 5
Checklist of questions to ask your doctor before having a tape inserted. You should let your doctor know if you have had a reaction in the past to tape or mesh materials such as polypropylene. You might find it helpful to ask your doctor the following questions before having an operation which involves a tape: What are the pros and cons of using a tape in my particular case? Could the operation be done without a tape? What is your experience of using this particular tape? What experience have your other patients had with this product? What is your experience of dealing with complications from this product? What should I expect to feel after my operation and for how long? Are there any specific side effects that I should let you know about after the surgery? What happens if the tape doesn t help my problem? If I have a complication, can the tape be removed and what would the consequences be? Is there a patient information leaflet that comes with the product? Can I have a copy? 6
Other sources of information The Royal College of Obstetricians and Gynaecologists has a statement about tape use, which includes some useful links to other websites, here: http://www.rcog.org.uk/news/rcog-statement-reportcommissioned-mhra-vaginal-tape-and-mesh-implants The FDA advice regarding tapes can be found here: http://www.fda.gov/medicaldevices/safety/alertsand Notices/ ucm142636.htm#popsui The NICE guidelines about mesh and tape procedures can be found on their website: www.nice.org.uk 7
Violence, Aggression and Harassment Control Policy We are committed to the well-being and safety of our patients and of our staff. Please treat other patients and staff with the courtesy and respect that you expect to receive. Verbal abuse, harassment and physical violence are unacceptable and will lead to prosecutions. Suggestions, Concerns and Complaints If you would like to provide feedback you can: Ask to speak to the ward or department manager. Write to us: Patient Advice and Liaison Services, 1st Floor, Cobbett House, Manchester Royal Infirmary, Oxford Road, Manchester M13 9WL Log onto the NHS Choices website www.nhs.uk - click on Comments. If you would like to discuss a concern or make a complaint: Ask to speak to the ward or department manager they may be able to help straight away. Contact our Patient Advice and Liaison Service (PALS) Tel: 0161 276 8686 e-mail: pals@cmft.nhs.uk. Ask for our information leaflet. We welcome your feedback so we can continue to improve our services. 8
Please use this space to write down any questions or concerns you may have. 9
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TIG 115/14 Produced July 2014 Review Date July 2016 (SF Taylor CM15811)